- a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant

Prospective

a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment

Detailed Description:

This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan. It will be conducted in close collaboration with the Pakistan MoH and Marie Stopes Society, Pakistan in several MoH-affiliated and Marie Stopes Society clinics that have experience with implants and sufficient expected flow of implant users per month. We will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrolment; and

a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Femplant services.

Eligibility

Ages Eligible for Study:

18 Years to 44 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Probability Sample

Study Population

women using Femplant as a primary method of contraception in Pakistan

Criteria

Inclusion Criteria:

To be eligible for inclusion, a woman must:

be aged 18-44 years, inclusive

be willing to sign an informed consent document

agree to return for follow-up visits

have decided to receive Femplant as a method of contraception and met the clinic criteria for eligibility of this method of contraception

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463254